CompletedNot Applicable

Three Dimensional Evaluation of Dento-Skeletal Effects of Leaf Self Expander in Cleft Lip and Palate Patients

Egypt20 participantsStarted 2023-09-01

Plain-language summary

This study aims to evaluate the dento-alveolar changes after maxillary expansion in cleft lip and palate patients by Leaf Self Expander, as compared to conventional Rapid Maxillary Expander using digital cast analysis and three-dimensional cone-beam computed tomography.

Who can participate

Age range3 Months – 24 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with unilateral or bilateral cleft lip and palate in mixed dentition. * Lip and palate repair was performed from 3 to 24 months of age. * Presence of maxillary constriction and need of maxillary expansion prior to secondary alveolar bone grafting. * Good periodontal health. Exclusion Criteria: * Previous orthodontic treatments. * Any systemic diseases. * Multiple carious lesions.

What they're measuring

Measurement of linear skeletal change

Timeframe: 6 months post-expansion

Trial details

NCT IDNCT07384338

SponsorAl-Azhar University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

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